MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR SWAN-GANZ CCOMBO V CCO/SVO2/CEDV THERMODILUTION CATHETER; CATHETER, OXIMETER, FIBER-OPTIC

Model Number 774F75

Device Problem Deflation Problem (1149)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/10/2021

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is anticipated.However the complaint cannot not be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation results when received.Lot number was not provided, therefore review of the manufacturing records could not be completed.

Event Description

It was reported that with this swan ganz catheter, there was a balloon deflation problem.No further information could be provided.There was no allegation of patient injury.The product was available for evaluation.

Manufacturer Narrative

One 774f75 catheter and a non-ew contamination shield were returned for examination.The reported event of "balloon deflation problem" was not confirmed.The balloon inflated clear, concentric, and remained inflated for 5 minutes without leakage.No visible damage or deterioration was found from the balloon latex and balloon bonding sites.The balloon deflated within 2 seconds without the syringe, and the balloon did not deflate with the syringe attached.All through lumens were patent without any leakage or occlusion.No visible damage was observed from the catheter body or returned syringe.The reported event could not be confirmed or replicated during the analysis, as the device responded appropriately during functional testing.It is not known if some procedural factors may have contributed to the event.The techniques for insertion, methods of using the catheter to obtain patient data information, and the occurrence of complications are well described in the literature.Balloon deflation difficulty can result in an occlusion of blood flow and possible distal ischemia.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.

• Brand Name: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV THERMODILUTION CATHETER
• Type of Device: CATHETER, OXIMETER, FIBER-OPTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco PR 00610
• MDR Report Key: 11885883
• MDR Text Key: 252989970
• Report Number: 2015691-2021-03152
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• PMA/PMN Number: K040287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 774F75
• Device Catalogue Number: 774F75
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1